(198 days)
The PhotoDerm PL is a system intended for the treatment of benign pigmented lesions and tattoos.
PhotoDerm PL is an electro optic medical device designed for effective photothermal treatment of benign pigmented lesions and tattoos non-invasively.
The provided text describes a 510(k) summary for the PhotoDerm® PL device. Here's an analysis of the acceptance criteria and the study based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance goal is implicitly to achieve clearance rates and adverse effect rates comparable to those of the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (PhotoDerm® PL) |
|---|---|
| Effectiveness: Clearance rates for benign pigmented lesions and tattoos comparable to predicate devices. | "The clearance rates... of the PhotoDerm PL were established." |
| "This data was compared to published data on the clearance rate... of predicate devices." Outcome: "ESC's opinion that this comparison demonstrates that the PhotoDerm PL is as safe and as effective as predicate devices in the treatment of benign pigmented lesions." | |
| Safety: Rate of occurrence of adverse effects comparable to predicate devices. | "The... rate of occurrence of adverse effects of the PhotoDerm PL were established." |
| "This data was compared to published data on the... adverse effects of predicate devices." Outcome: "ESC's opinion that this comparison demonstrates that the PhotoDerm PL is as safe and as effective as predicate devices in the treatment of benign pigmented lesions." | |
| Technical Equivalence: Technical specifications within the range of predicate devices. | "ESC has performed a detailed comparison of the technical specifications of these predicate devices and the PhotoDerm PL. The results have documented that the system specifications of the PhotoDerm PL are well within the range of the technical specifications of the predicate devices." |
| Safety in Surrounding Tissues (Theoretical): Minimize adverse effects in surrounding tissues. | "A theoretical study was conducted to establish the temperature distribution... evaluated. It is the view of ESC Medical Systems that this analysis demonstrates... safe in minimizing the adverse effects in the surrounding tissues." |
| Compliance with Standards: | Conforms with IEC601.1-1. |
| Efforts made to comply with 21 CFR 1040.1 FDA laser performance standard (where applicable, despite not being a laser device). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "a multi-center clinical study." The exact number of patients or lesions included in this study is not provided.
- Data Provenance: The study was "multi-center," suggesting data from multiple clinical sites. The country of origin is not specified, but the applicant (ESC Medical Systems, Ltd.) is based in Israel, so it's possible some or all centers were located there or elsewhere globally. The study was prospective as it involved treating patients with the PhotoDerm PL and then analyzing the results. The comparison to predicate devices relied on "published data," which would be retrospective in relation to the PhotoDerm PL study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts, their qualifications, or their role in establishing ground truth for the clinical study. It states that "The clearance rates and rate of occurrence of adverse effects of the PhotoDerm PL were established," implying clinical assessment, but not specifying who performed these assessments or how inter-observer variability was handled.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. The PhotoDerm PL is a treatment device, not an AI diagnostic tool intended to assist "human readers" (e.g., radiologists, pathologists).
- The study design was a clinical trial of the device's treatment efficacy, not an assessment of reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in the sense that the device's performance was evaluated independently. The clinical study assessed the PhotoDerm PL's ability to treat lesions directly. There is no "human-in-the-loop" interaction in the operational sense of an AI diagnostic tool; the device performs the treatment.
- However, the evaluation itself certainly involved human clinicians administering the treatment and assessing its outcomes.
7. The Type of Ground Truth Used
The ground truth for the effectiveness and safety of the PhotoDerm PL was based on clinical outcomes data obtained from a multi-center clinical study (e.g., observed clearance rates of lesions, observed rates of adverse effects). This was then implicitly compared to similar clinical outcome data from predicate devices, likely from published clinical trials or real-world evidence for those devices.
8. The Sample Size for the Training Set
The concept of a "training set" is not directly applicable here as the PhotoDerm PL is a medical device for treatment, not an AI algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI algorithm, this question is not relevant to the PhotoDerm PL device as described. The device's design and operating parameters would be based on engineering principles and understanding of photothermal interactions, rather than machine learning on a training dataset.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.